Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma

NCT02801955 | Completed

• 1 other identifier: GastCancTmMark2016
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.

Conditions

Gastric Adenocarcinoma

Keywords

gastric adenocarcinoma; tumor markers; peritoneal cytology

Outcome Measures

Primary Outcomes (1)

• TNM stage

  TNM stage based on the 7th American Joint Committee on Cancer/International Union Against Cancer tumor, node, metastasis system.

  through pathologic report completion, an average of 1 month

Secondary Outcomes (2)

• peritoneal washing cytology

  through pathologic report completion, an average of 1 month

• recurrence/death

  through follow-up period, an average of 24 months

Study Arms (1)

tumor marker

serum CEA and CA 19-9 levels in patients with curative gastrectomy preoperatively and peritoneal CEA and CA 19-9 levels in patients taken at the beginning of curative gastrectomy via sampling of peritoneal washing aspirate

Procedure: gastrectomy; Procedure: sampling of peritoneal washing aspirate

Interventions

gastrectomy PROCEDURE

radical total/subtotal gastrectomy with D2 lymph node dissection

tumor marker

sampling of peritoneal washing aspirate PROCEDURE

After thoroughly examination of the peritoneal cavity revealing the absence of peritoneal dissemination, the peritoneal cavity was washed with 200 ml of saline, and at least one third was aspirated from several regions of the peritoneal cavity, including near the primary tumor, the left and right subphrenic areas and the pouch of Douglas with suction tubes to a clean bottle and designated as the peritoneal sample for determination of peritoneal levels of CEA and CA 19-9.

tumor marker

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

gastric adenocarcinoma treated with curative gastrectomy

You may qualify if:

• Endoscopically proven gastric adenocarcinoma
• Standard gastrectomy and a D2 lymph node dissection;
• Desire to attend the study protocol

You may not qualify if:

• Metastatic or overt peritoneal disseminated cancer
• Undesired reaction to attend the study protocol

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Mustafa Hasbahceci

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Gastrectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• mustafa hasbahceci, assoc. prof.

  bezmialem vakif university faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of General Surgery

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 16, 2016
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)